Recall Z-1057-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1057-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-11-29, terminated 2020-04-02. It names one FDA 510(k) clearance: K072619. Product: NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.. Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Terminated: 2020-04-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K072619 — NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTSZimmer, Inc.·cleared 2007-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

Data sourced from openFDA. This site is unofficial and independent of the FDA.